Miller C M, Furtado D, Smith F M, Godwin H N, Hogan L C, Letendre D E
Am J Hosp Pharm. 1982 Aug;39(8):1302-5.
The accuracy of three sterility-testing methods in detecting low-level contamination in deliberately contaminated intravenous solutions was studied. One-liter bags of 5% dextrose (D5W) and 0.9% sodium chloride (saline injections were contaminated with Staphylococcus epidermidis and Pseudomonas aeruginosa; approximately 10(1) viable bacteria were injected into each bag. Two membrane-filtration methods (Ivex-2 and Addi-Chek) and one aliquot method [twice concentrated trypic soy broth (2X-TSB)] were used to test each of 10 diliberately contaminated solutions for both D5W and saline; 500 ml of each liter bag was filtered or added to 2X-TSB. Incubation containers were stored at 37 degrees C and inspected at 24, 48, and 72 hours for turbidity. There was no significant difference among the three methods in the detection of contaminated saline solutions. The Addi-Chek system was significantly less effective in detecting contamination in D5W than either of the other methods. It is concluded that the Ivex-2 system is accurate and the easiest-to-use system of the three tested.
研究了三种无菌检测方法在检测故意污染的静脉输液中低水平污染情况时的准确性。将含有表皮葡萄球菌和铜绿假单胞菌的1升袋装5%葡萄糖（D5W）和0.9%氯化钠（生理盐水注射液）进行污染；向每个袋子中注入约10¹个活细菌。使用两种膜过滤方法（Ivex - 2和Addi - Chek）和一种等分试样方法[两倍浓缩胰蛋白胨大豆肉汤（2X - TSB）]对10份故意污染的D5W和生理盐水溶液分别进行检测；将每升袋子中的500毫升进行过滤或加入到2X - TSB中。培养容器在37摄氏度下储存，并在24、48和72小时检查是否有浑浊。在检测污染的生理盐水溶液方面，这三种方法之间没有显著差异。Addi - Chek系统在检测D5W中的污染方面明显不如其他两种方法有效。得出的结论是，Ivex - 2系统是所测试的三种系统中准确且最易于使用的系统。
